Pharmaceuticals and medical devices
In a GMP environment it is not enough to do it: you have to be able to prove it. We work on line performance, the reliability of critical utilities and the quality of data in pharmaceutical and medical device plants, knowing that every intervention and every deviation leaves a documentary trail and that a utility out of range can compromise an entire batch.
What we find in this sector
Shutdown windows that are very limited and very expensive, forcing careful judgement about what goes into each one.
Long changeovers and batch changes, with a great deal of cleaning and verification in between, which eat into line performance.
Critical utilities — purified water, compressed air, clean steam, HVAC — with continuous qualification and monitoring requirements.
Work plans that have to live alongside qualification and validation, without every change triggering an endless change control.
Documentary pressure: if it is not recorded, it did not happen. And the data that serves quality is not always the data that serves management.
Production, maintenance and quality working side by side, with criteria that do not always coincide and priorities that clash.
OEE analysis by line, with a real breakdown of the losses: availability, performance and right first time.
Reduction of changeover and batch-change times without touching what qualification protects.
An organisational model based on autonomous units and a daily management routine on site.
Standardisation of methods and preparation of the Production Operating Manual (MOP).
Analysis of the raw materials and packaging materials warehouse, and its synchronisation with the programme.
Maintenance plans for critical utilities and process equipment, aligned with the qualification requirements.
Maintenance management audit focused on traceability and documentary compliance.
Root cause analysis of deviations and incidents with an impact on product.
Asset criticality, renewal plan and obsolescence management.
Planning of major shutdowns and of expansion projects without compromising qualification.
Support with ISO 13485, ISO 9001 and ISO 55001.
Implementation of MES/CMMS systems (MES/GMAO) with a data structure, records and traceability that stand up to audit.
Calculation of OEE and availability from real plant data, not from a parallel spreadsheet.
Integration with SCADA and with the continuous utility monitoring systems.
A single dashboard covering production, maintenance and cost for the plant committee.
Deciding what to measure on each critical asset before instrumenting anything.